Status:
COMPLETED
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
42-72 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with ro...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Healthy infants aged 6 weeks (42-72 days) at time of enrolment
- Available for the entire study period
- Exclusion Criteria
- Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis or Hib vaccines
- A previous anaphylactic reaction to any vaccine or vaccine-related component
- Contraindication to vaccination with pneumococcal, Hib, diphtheria, tetanus, pertussis, polio, hepatitis B or measles vaccines
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT00452790
Start Date
June 1 2007
End Date
February 1 2010
Last Update
March 24 2011
Active Locations (12)
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1
Sector-12, Chandigarh, India, 160 012
2
Sector-32 B, Chandigarh, India, 160031
3
Bangalore, Karnataka, India, 560 034
4
Bangalore, Karnataka, India, 560017